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A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

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ClinicalTrials.gov Identifier: NCT03398135
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
AbbVie

Tracking Information
First Submitted Date  ICMJE January 8, 2018
First Posted Date  ICMJE January 12, 2018
Last Update Posted Date April 19, 2019
Actual Study Start Date  ICMJE August 28, 2018
Estimated Primary Completion Date December 4, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
Percentage of participants with clinical remission per adapted Mayo Score at Week 52 [ Time Frame: Week 52 ]
Clinical remission per adapted Mayo Score.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03398135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 20, 2019)
  • Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0 [ Time Frame: Week 52 ]
    Clinical remission per adapted Mayo Score.
  • Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction) [ Time Frame: Week 52 ]
    Participants who discontinued corticosteroid use.
  • Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction). [ Time Frame: Week 52 ]
    Clinical remission per adapted Mayo Score.
  • Percentage of participants with endoscopic remission at Week 52 [ Time Frame: Week 52 ]
    Endoscopic remission per endoscopy subscore.
  • Ulcerative Colitis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.
  • Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52 [ Time Frame: 52 weeks ]
    Participants who underwent surgery related to UC.
  • Percentage of participants with hospitalization through Week 52 [ Time Frame: 52 weeks ]
    Participants with an event that results in admission to the hospital.
  • 36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The SF-36 is an indicator of overall health status.
  • Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
  • Percentage of participants with endoscopic improvement at Week 52 [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.
  • Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction) [ Time Frame: Week 52 ]
    Clinical remission per full Mayo Score.
  • Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0 [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.
  • Percentage of participants with clinical response per adapted Mayo score at Week 52 [ Time Frame: Week 52 ]
    Clinical response per adapted Mayo score.
  • Percentage of participants with histologic remission at Week 52 [ Time Frame: Week 52 ]
    Histologic remission per Geboes Score.
  • Percentage of participants with mucosal healing at Week 52 [ Time Frame: Week 52 ]
    Mucosal healing defined as endoscopic and histologic remission.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2018)
  • Percentage of participants with endoscopic improvement at Week 52 [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.
  • Percentage of participants with clinical remission per full Mayo Score at Week 52 in subjects with a full Mayo Score of 6 to 12 at Baseline (of Induction) [ Time Frame: Week 52 ]
    Clinical remission per full Mayo Score.
  • Percentage of participants who discontinued corticosteroid use, remained corticosteroid free for 90 days, and achieved clinical remission per adapted Mayo Score at Week 52 in subjects taking steroids at Baseline (of induction). [ Time Frame: Week 52 ]
    Clinical remission per adapted Mayo Score.
  • Percentage of participants with clinical remission per adapted Mayo Score at Week 52 in subjects with a clinical remission at Week 0 [ Time Frame: Week 52 ]
    Clinical remission per adapted Mayo Score.
  • Percentage of participants who discontinued corticosteroid use at Week 52 in subjects who were taking steroids at Baseline (of induction) [ Time Frame: Week 52 ]
    Participants who discontinued corticosteroid use.
  • Percentage of participants with endoscopic improvement at Week 52 in participants with endoscopic improvement at Week 0 [ Time Frame: Week 52 ]
    Endoscopic improvement per endoscopy subscore.
  • Percentage of participants with clinical response per adapted Mayo score at Week 52 [ Time Frame: Week 52 ]
    Clinical response per adapted Mayo score.
  • Percentage of participants with endoscopic remission at Week 52 [ Time Frame: Week 52 ]
    Endoscopic remission per endoscopy subscore.
  • Percentage of participants with hospitalization through Week 52 [ Time Frame: 52 weeks ]
    Participants with an event that results in admission to the hospital.
  • Ulcerative Colititis Symptom Questionnaire (UC-SQ): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The UC-SQ is a patient questionnaire to assess severity of ulcerative colitis symptoms.
  • Percentage of participants with histologic remission at Week 52 [ Time Frame: Week 52 ]
    Histologic remission per Geboes Score.
  • Percentage of participants with mucosal healing at Week 52 [ Time Frame: Week 52 ]
    Mucosal healing defined as endoscopic and histologic remission.
  • Inflammatory Bowel Disease Questionnaire (IBDQ): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The IBDQ is used to assess the quality of life of patients with inflammatory bowel disease.
  • Percentage of participants with Ulcerative Colitis (UC)-related surgeries through Week 52 [ Time Frame: 52 weeks ]
    Participants who underwent surgery related to UC.
  • 36-Item Short Form Health Status Survey (SF-36): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The SF-36 is an indicator of overall health status.
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue): Change from Week 0 to Week 52 [ Time Frame: Week 0, Week 52 ]
    The FACIT-Fatigue is a validated tool that measures an individual's level of fatigue during their usual daily activities over the past week.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects With Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065
Brief Summary

The purpose of this study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

This study consists of three sub-studies: Substudy 1 is a 52-week, randomized, double-blind, placebo-controlled maintenance study; Substudy 2 is 52-week, randomized, exploratory maintenance study; and Substudy 3 is an open-label long-term extension study for subjects who completed Substudy 1 or 2.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Ulcerative Colitis (UC)
Intervention  ICMJE
  • Drug: risankizumab
    subcutaneous (SC) injection
    Other Names:
    • ABBV-066
    • BI 655066
  • Drug: placebo for risankizumab
    subcutaneous (SC) injection
Study Arms  ICMJE
  • Experimental: Substudy 2: Open-label Risankizumab Dose 1
    Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
    Intervention: Drug: risankizumab
  • Experimental: Substudy 1: Double-blind Risankizumab Dose 2
    Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
    Intervention: Drug: risankizumab
  • Experimental: Substudy 2: Open-label Risankizumab Dose 2
    Participants randomized to receive risankizumab dose 2 administered by subcutaneous (SC) injection.
    Intervention: Drug: risankizumab
  • Experimental: Substudy 3: Open-label Extension Risankizumab
    Participants who completed Sub-study 1 or 2 receive open-label risankizumab in Sub-study 3.
    Intervention: Drug: risankizumab
  • Placebo Comparator: Substudy 1: Double-blind Placebo
    Participants randomized to receive placebo for risankizumab administered by subcutaneous (SC) injection.
    Intervention: Drug: placebo for risankizumab
  • Experimental: Substudy 1: Double-blind Risankizumab Dose 1
    Participants randomized to receive risankizumab dose 1 administered by subcutaneous (SC) injection.
    Intervention: Drug: risankizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 8, 2018)
760
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2024
Estimated Primary Completion Date December 4, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have completed Study M16-065 or Study M16-067 and have achieved clinical response

Exclusion Criteria:

  • Subjects who have a known hypersensitivity to risankizumab or the excipients of any of the study drugs or the ingredients of chinese hamster ovary (CHO) or had an adverse event (AE) during Studies M16-065 or M16-067 that in the Investigator's judgment makes the subject unsuitable for this study
  • Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study
  • Subject is not in compliance with prior and concomitant medication requirements throughout Studies M16-065 and M16-067
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 847.283.8955 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE American Samoa,   Argentina,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Denmark,   Egypt,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Serbia,   Singapore,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries Australia,   Czechia
 
Administrative Information
NCT Number  ICMJE NCT03398135
Other Study ID Numbers  ICMJE M16-066
2016-004676-22 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
URL: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Responsible Party AbbVie
Study Sponsor  ICMJE AbbVie
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: AbbVie Inc. AbbVie
PRS Account AbbVie
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP